JERUSALEM -- (Business Wire)
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the Food and
Drug Administration (FDA) approval of the first generic equivalent to
Nexium (esomeprazole magnesium) Delayed-Release Capsules in the United
States.
Teva is preparing to launch the product in the near future.
Nexium Delayed-Release Capsules, marketed by AstraZeneca, had annual
sales of approximately $6 billion in the United States, according to IMS
data as of November 2014.
About Teva
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical
company, committed to increasing access to high-quality healthcare by
developing, producing and marketing affordable generic drugs as well as
innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world's leading
generic drug maker, with a global product portfolio of more than 1,000
molecules and a direct presence in approximately 60 countries. Teva's
Specialty Medicines businesses focus on CNS, respiratory, oncology,
pain, and women's health therapeutic areas as well as biologics. Teva
currently employs approximately 45,000 people around the world and
reached $20.3 billion in net revenues in 2013.
Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially COPAXONE®(including
competition from orally-administered alternatives, as well as from
potential purported generic equivalents); the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters; our
ability to achieve expected results from the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; our ability to
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and Europe
of our patent settlement agreements; our exposure to currency
fluctuations and restrictions as well as credit risks; the effectiveness
of our patents, confidentiality agreements and other measures to protect
the intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; uncertainties related to our recent management changes; the
effects of increased leverage and our resulting reliance on access to
the capital markets; any failure to recruit or retain key personnel, or
to attract additional executive and managerial talent; adverse effects
of political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations; interruptions in our
supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
or breaches of our data security; competition for our generic products,
both from other pharmaceutical companies and as a result of increased
governmental pricing pressures; competition for our specialty
pharmaceutical businesses from companies with greater resources and
capabilities; decreased opportunities to obtain U.S. market exclusivity
for significant new generic products; potential liability in the U.S.,
Europe and other markets for sales of generic products prior to a final
resolution of outstanding patent litigation; any failures to comply with
complex Medicare and Medicaid reporting and payment obligations; the
impact of continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; potentially significant increases in tax liabilities; the
effect on our overall effective tax rate of the termination or
expiration of governmental programs or tax benefits, or of a change in
our business; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31, 2013 and in our
other filings with the U.S. Securities and Exchange Commission.
Forward-looking statements speak only as of the date on which they are
made and we assume no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Contacts:
IR:
United States
Kevin C. Mannix, (215) 591-8912
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
United States
Ran
Meir, (215) 591-3033
or
PR:
Israel
Iris Beck
Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, (215) 591-8974
Source: Teva Pharmaceutical Industries Ltd.
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